Cleared Traditional

K962292 - HEARSAVER

K962292 · Emtech Laboratories · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
137d
Days
-
Risk

K962292 is an FDA 510(k) clearance for the HEARSAVER. Classified as Protector, Hearing (insert) (product code EWD).

Submitted by Emtech Laboratories (Hardy, US). The FDA issued a Cleared decision on October 29, 1996 after a review of 137 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Emtech Laboratories devices

FDA 510(k) Submission Details - K962292

510(k) Number K962292 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1996
Decision Date October 29, 1996
Days to Decision 137 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d slower than avg
Panel avg: 89d · This submission: 137d
Pathway characteristics
Predicate-based equivalence.

EWD Device Classification - Class 0,

Product Code EWD Protector, Hearing (insert)
Device Class -